A micro-emulsion type artificial tear

An emulsion preparation and emulsifier technology, which is applied in the directions of emulsion delivery, sensory disease, drug combination, etc., can solve the problems of industrial production and clinical safety application, emulsifier not suitable for ophthalmic emulsion, thermodynamic instability, etc. Easy to sterilize, high stability, good stability

Inactive Publication Date: 2006-12-20
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ordinary emulsions are thermodynamically unstable systems, and their long-term storage stability is usually not good; in addition, ordinary emulsions often have certain stability problems in the subsequent sterilization process, which brings certain problems to industrial production and clinical safety applications. Difficulties
[0017] Emulsifiers are an essential and important ingredient in emulsion prescriptions, but most surfactants have strong irritation and toxic side effects on eye tissues, and are not suitable as emulsifiers for ophthalmic emulsions
Other surfactants with good physiological compatibility (such as phospholipids) are often difficult to form stable emulsions with specific oils because of their weak emulsifying ability.

Method used

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  • A micro-emulsion type artificial tear

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Prescription composition:

[0067] Castor oil 6g

[0068] Polyoxyethylene castor oil 15g

[0069] Carbomer 0.05g

[0070] Glycerin 26g

[0071] Appropriate amount of sodium hydroxide

[0072] Benzalkonium Chloride 0.05g

[0073] Appropriate amount of purified water

[0074] Makes 1000ml

[0075] Preparation method: weigh each component according to the composition of the prescription, mix castor oil, polyoxyethylene castor oil and glycerin at 60°C, then add an appropriate amount of purified water (water for injection), shear and emulsify to obtain colostrum, and then use Homogenize with a high-pressure homogenizer (pressure about 140,000kPa, homogenize for 4 hours), then adjust the viscosity to 2.6-3.5cp with carbomer (Nuoyu Chemical Co., Ltd.) aqueous solution; then adjust to pH6.2 with sodium hydroxide solution -8; subsequently, add the prescribed amount of benzalkonium chloride, make up to 1000ml ...

Embodiment 2

[0092] Prescription composition:

[0093] Tricaprylic Capric Glyceride 6g

[0094] Polyoxyethylene castor oil 15g

[0095] Carbomer 0.05g

[0096] Glycerin 26g

[0097] Appropriate amount of sodium hydroxide

[0098] Benzalkonium Chloride 0.05g

[0099] Appropriate amount of purified water

[0100] Makes 1000ml

[0101] Preparation method: Weigh each component according to the composition of the prescription, mix tricaprylic capric glyceride, polyoxyethylene castor oil and glycerin evenly at 60°C, then add an appropriate amount of purified water, shear and emulsify to obtain colostrum, and then use Homogenize with a high-pressure homogenizer (pressure about 100,000kPa, homogenize for 1 hour), then adjust the viscosity to 2.6-3.5cp with carbomer aqueous solution; then adjust the pH to 6.2-8 with sodium hydroxide solution; then, add the prescription Measure benzalkonium chloride, make up to 1000ml with purifi...

Embodiment 3

[0103] Prescription composition:

[0104] Castor oil 0.1g

[0105] Polyoxyethylene castor oil 10g

[0106] Carbomer 0.05g

[0107] Glycerin 26g

[0108] Appropriate amount of sodium hydroxide

[0109] Benzalkonium Chloride 0.05g

[0110] Appropriate amount of purified water

[0111] Makes 1000ml

[0112] Preparation method: weigh each component according to the composition of the prescription, mix castor oil, polyoxyethylene castor oil and glycerin at 60°C, then add an appropriate amount of purified water, shear and emulsify to obtain colostrum, and then use a high-pressure homogenizer Homogenize (pressure about 100,000kPa, homogenize for 6 hours), then adjust the viscosity to 2.6-3.5cp with carbomer aqueous solution; then adjust the pH to 6.2-8 with sodium hydroxide solution; then, add the prescribed amount of benzalkonium chloride Ammonium, make up to 1000ml with purified water, filter the obtained product ...

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Abstract

The invention relates to an eye microemulsion and process for preparation, wherein the microemulsion is prepared from oil phase, emulsifying agent, adhesion promoter, osmoregulation agent, bacteria inhibitor, sodium hydroxide and purified water through the steps of shearing and high pressure homogenizing, wherein non-ionic surface active agents such as polyoxyethylene, castor oil or polyoxyethylene hydrogenated castor oil is used as the emulsifying agent, and the auxiliary materials also include glycerin, castor oil or GTCC.

Description

technical field [0001] The invention relates to a microemulsion preparation, in particular to a microemulsion preparation for local application to eyes, and also relates to a preparation method of the ophthalmic microemulsion preparation. Background technique [0002] Tears are an innate defense mechanism, which contains lysozyme to make the surface of the eyeball to a certain extent reduce the effect of infection or other harmful substances, such as dust, foreign bodies and so on. In addition, it keeps the corneal surface smooth and produces clear vision, and forms a thin tear film on the corneal epithelium (the surface of the eyeball) to continuously moisten and lubricate the eyeball, making your eyes feel comfortable. [0003] The normal tear film covers the cornea and conjunctiva, and this film can be subdivided into three layers: lipid layer, aqueous layer and mucus layer from outside to inside. [0004] Lipid layer: It is secreted by the meibomian glands of the eyelid...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61P27/02
Inventor 甘勇甘莉王昕朱春柳
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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